K093978 is an FDA 510(k) clearance for the EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 11, 2010, 138 days after receiving the submission on December 24, 2009.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K093978 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2009 |
| Decision Date | May 11, 2010 |
| Days to Decision | 138 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |